Infuse is a bio-engineered bone graft device that is marketed by Medtronic for lumbar surgery. It is intended as a substitute for the traditional surgical procedure involving the taking of a bone graft from the patients hip. The advantage of this product is that no surgery is needed to remove bone from the patient's hip reducing pain and shortening recovery times. However, the introduction of foreign material into the body creates other risks.
The lawsuits allege that Medtronic failed to reveal side effects which Medtronic knew were likely in order to increase sales of the product. These side effects include uncontrolled bone growth called ectopic bone growth that resulted in failures of many surgeries. The active fusion ingredient in the Infuse product is rhBMP-2. The letters BMP stand for Bone Morphogenetic Protein. This ingredient is designed to stimulate bone growth in the spine so that the vertebra will fuse together to relieve back pain.
Injured back surgery patients allege that Medtronic understated the risk of uncontrolled bone growth, inflamatory reactions, retrograde ejaculation, urinary retention, bone reabsorption, implant displacement, sterility, and cancer.
The lawsuits also allege that Medtronic illegally marketed the Infuse product "off-label". Off label marketing means that the company promoted the product for medical uses for which it was not approved by the FDA. Off label use of drugs and medical devices is permissable by medical professionals and can be beneficial to patients but a pharmaceutical drug or device manufacturer is prohibited by the FDA regulations from promoting or marketing products for uses that were not approved by the FDA.
The primary off label use of the products allegedly promoted by Medtronic was for posterior lumbar fusion surgery. Infuse was only approved by the FDA for anterior approach lumbar fusions. This means that Infuse was approved for for spine surgeries with a surgical approach through the abdomen or the front of a person rather than a surgical approach to the spine through the back. It is alleged that Medtronic paid highly respected surgeons it calls "opinion leaders" to influence surgeons to increase off label use of Infuse in posterior spine surgical procedures.
It appears that the Medtronic Infuse bone graft marketing campaign may be yet another incident of a medical device company putting its own interests in progit ahead of the safety of medical patients.
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